Tiziana Life Sciences Ltd (NASDAQ:TLSA) has reported imaging results from the third patient with multiple system atrophy (MSA) to complete dosing in its ongoing Phase 2 clinical trial of intranasal foralumab, with PET scans showing reductions in brain inflammation following treatment.
The company said quantitative analysis of PET imaging demonstrated reductions in inflammatory activity in brain regions commonly affected by MSA, including the basal ganglia and cerebellar white matter.
According to Tiziana, the third patient showed reductions of up to 34% in standardized uptake value (SUV) and 26% in standardized uptake value ratio (SUVR) in the most affected areas.
The findings were consistent with results previously reported in the first two patients, who each showed reductions of up to approximately 35% in SUV and 24% in SUVR, the company said.
"The consistency of these PET findings across MSA patients, based on our lab's approaches, remains encouraging," Tarun Singhal, founding director of the NeuroPET Program at Brigham and Women's Hospital and associate professor of neurology at Harvard Medical School, said in a statement.
"In this third patient to complete dosing, we again saw quantitative reductions similar to those previously seen in the first two patients and reinforce the PET imaging evidence supporting biological activity of intranasal foralumab in dampening neuroinflammation in this devastating disease,” Singhal said.
“Correlation with clinical features and further confirmation with additional quantitative techniques should be performed."
Tiziana CEO Ivor Elrifi said the latest results build on earlier findings from the company's MSA program as well as studies in non-active secondary progressive multiple sclerosis and moderate Alzheimer's disease.
"Seeing reproducible reductions in neuroinflammation on PET imaging in a third MSA patient further strengthens our confidence in the potential of intranasal foralumab," Elrifi said.
"These data build directly on the positive signals already observed in the first two MSA patients, as well as in non-active secondary progressive multiple sclerosis and moderate Alzheimer's disease. We remain committed to advancing this program for patients who currently have no approved disease modifying options."
According to the company, PET imaging comparisons conducted before and after treatment showed lower radiotracer uptake across disease-relevant brain regions, suggesting a reduction in neuroinflammatory activity following administration of intranasal foralumab.
Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system through mucosal tolerance mechanisms while aiming to reduce inflammation without the systemic toxicities associated with traditional anti-CD3 therapies.
Multiple system atrophy is a rare, progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism and cerebellar ataxia. There are currently no approved disease-modifying treatments for the condition.
Tiziana said it plans to continue evaluating intranasal foralumab in additional patients to further assess the therapy's potential to reduce neuroinflammation in MSA.